FDA.reportPublic FDA data

varenicline tartrate

Product NDC
42571-460
11-digit product format
425710460
Labeler code
42571
Product ID
42571-460_426f1bdc-211b-b246-e063-6394a90a8de3
Type
HUMAN PRESCRIPTION DRUG
Nonproprietary name
varenicline tartrate
Dosage form
TABLET, FILM COATED
Route
ORAL
Labeler
Micro Labs Limited
Application
ANDA218302
Marketing category
ANDA
Marketing start
2025-12-01
Substance
VARENICLINE TARTRATE
Active strength
1 mg/1
Pharmacologic classes
Cholinergic Agonists [MoA], Cholinergic Receptor Agonist [EPC], Partial Cholinergic Nicotinic Agonist [EPC], Partial Cholinergic Nicotinic Agonists [MoA]
NDC exclude flag
No
Listing certified through
2026-12-31
Current FDA listing
Yes

Additional Listing Data#

Finished product
Yes
Brand name base
varenicline tartrate
Listing expiration
2026-12-31

Active Ingredients#

Ingredient, Strength table
IngredientStrength
VARENICLINE TARTRATE1 mg/1

Harmonized Identifiers#

Field, Values table
FieldValues
Unii82269ASB48
Rxcui636671, 636676, 749289, 749788

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
f0bb1b01-df09-3a97-b952-a960743e615cProduct name820260223
317a11f5-b985-4a71-b48a-5c9c00753d1cProduct name120220511

DailyMed Package Descriptions#

Package NDC, Product, Description table
Package NDCProductDescriptionFormQuantityStrengthSPL version
42571-460-82varenicline tartrate56 in 1 BOTTLETABLET, FILM COATED561
42571-460-88varenicline tartrate56 in 1 BLISTER PACKTABLET, FILM COATED561
42571-460-88varenicline tartrate1 in 1 CARTONTABLET, FILM COATED11

DailyMed RxNorm Mappings#

RxCUI, RxNorm string, TTY table
RxCUIRxNorm stringTTYDailyMedSPL version
749289{11 (varenicline 0.5 MG Oral Tablet) / 42 (varenicline 1 MG Oral Tablet) } PackGPCKee603a5d-9a3c-4dbd-ba89-faf253dc8c421
749788{56 (varenicline 1 MG Oral Tablet) } PackGPCKee603a5d-9a3c-4dbd-ba89-faf253dc8c421
636671varenicline 0.5 MG Oral TabletPSNee603a5d-9a3c-4dbd-ba89-faf253dc8c421
636676varenicline 1 MG Oral TabletPSNee603a5d-9a3c-4dbd-ba89-faf253dc8c421
749788varenicline 1 MG Oral Tablet 56 Count PackPSNee603a5d-9a3c-4dbd-ba89-faf253dc8c421
749289varenicline starting month pack 0.5 MG (11), 1 MG (42) Tablet PackPSNee603a5d-9a3c-4dbd-ba89-faf253dc8c421
636671varenicline 0.5 MG Oral TabletSCDee603a5d-9a3c-4dbd-ba89-faf253dc8c421
636676varenicline 1 MG Oral TabletSCDee603a5d-9a3c-4dbd-ba89-faf253dc8c421
636671varenicline 0.5 MG (as varenicline tartrate 0.85 MG) Oral TabletSYee603a5d-9a3c-4dbd-ba89-faf253dc8c421
636676varenicline 1 MG (as varenicline tartrate 1.71 MG) Oral TabletSYee603a5d-9a3c-4dbd-ba89-faf253dc8c421
749788varenicline 1 MG Oral Tablet 56 Count PackSYee603a5d-9a3c-4dbd-ba89-faf253dc8c421
749788varenicline continuing months of therapy PackSYee603a5d-9a3c-4dbd-ba89-faf253dc8c421
749289varenicline first month of therapy PackSYee603a5d-9a3c-4dbd-ba89-faf253dc8c421
749289varenicline starting month Pack, 53 Oral TabletsSYee603a5d-9a3c-4dbd-ba89-faf253dc8c421

Packages#

Package NDC, 11-digit format, Description table
Package NDC11-digit formatDescriptionUnitsMarketing startSampleExclude flagStatus
42571-460-824257104608256 TABLET, FILM COATED in 1 BOTTLE (42571-460-82) 2025-12-01NoNoCurrent
42571-460-88425710460881 BLISTER PACK in 1 CARTON (42571-460-88) / 56 TABLET, FILM COATED in 1 BLISTER PACK1 blister pack2025-12-01NoNoCurrent